MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTUA; IMPLANTABLE DEVICE

Model Number V273

Device Problems Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)

Patient Problems Loss of consciousness (2418); Syncope/Fainting (4411); Asystole (4442)

Event Date 10/01/2023

Event Type  Injury  

Event Description

It was reported that the health care professional (hcp) had difficulty interrogating this cardiac resynchronization therapy pacemaker (crt-p).The patient was experiencing pauses and was taken to the emergency room (er) via the ambulance.An alert was received which found the device to be in safety mode.The patient experienced 8-10 second pauses due to oversensing with syncope.Subsequently, the device was explanted and replaced successfully.This device has been returned and is in the process of device analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode had undergone resets and that bradycardia therapy remained available.The system resets occurred during a telemetry session while communicating with the latitude remote monitoring system which caused the device to enter safety mode.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption and subsequent reversion to safety mode operation.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.

Event Description

It was reported that the health care professional (hcp) had difficulty interrogating this cardiac resynchronization therapy pacemaker (crt-p).The patient was experiencing pauses and was taken to the emergency room (er) via the ambulance.An alert was received which found the device to be in safety mode.The patient experienced 8-10 second pauses due to oversensing with syncope.Subsequently, the device was explanted and replaced successfully.This device has been returned and is in the process of device analysis.No additional adverse patient effects were reported.

• Brand Name: INTUA
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17896299
• MDR Text Key: 325241629
• Report Number: 2124215-2023-55683
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536670
• UDI-Public: 00802526536670
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/13/2016
• Device Model Number: V273
• Device Catalogue Number: V273
• Device Lot Number: 118147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male